Category: News

Prodia The CRO team, represented by Erizal Sugiono (Director) and Rosalia Napitupulu (Business Development Manager), attended a forum group discussion initiated by Badan Pengawas Obat dan Makanan (BPOM) on October 31, 2024, held in Fairmont Hotel, Jakarta.

The topic of this discussion was “A Blueprint for Innovation Success: Optimal Quality of Clinical Trial Centers and Practitioners”. The event was held as a follow up of the Cooperation Agreement between BPOM, the Ministry of Health (MoH), and the National Research and Innovation Agency (BRIN) which was signed on July 19, 2024.

The scope of cooperation agreement includes the coordination in the clinical research approval, clinical research center mapping and guidance, clinical research registry, and improvement of clinical research practitioners competency. It is hoped that by the synergy in national policies related to research development, and utilization of science and technology, as well as clinical trial services and supervision, can be achieved.

The roles and duties of BPOM in clinical trials were described by Ria Christine Siagian, Director of Drug Registration, BPOM. The responsibilities include assessing applications for approval of clinical trial implementation (PPUK), monitoring and evaluating the conducting of clinical trials, mapping clinical trial centers, providing training in good clinical trial methods (CUKB), and disseminating PPUK data and inspection findings.

According to Indri Rooslamiati (the representative of the Directorate General of Health Services, MoH), the role of the MoH in improving the quality and safety of clinical trial implementation in Indonesia paved by the establishment of Indonesia Clinical Research Center (INA-CRC), which is a one-stop solution for the implementation of clinical research. The INA-CRC initiative includes transparency of procedures and digitalization of the Material Transfer Agreement (MTA) submission, revamping clinical study that registry through the Indonesia Clinical study Registry (INA-CRR) website, and the establishment of National Ethics Committee. The data between clinical trial approval (BPOM) will be interfaced with INA-CRC.

According to Ramatun Anggraini Kiemas (Deputy for Research and Innovation Facilitation—BRIN), BRIN is in charge of bolstering and coordinating institutions through the creation and accreditation of the Health Ethics Commission, financing the conduct of pre-clinical and clinical trials, and overseeing and carrying out clinical trials, enhancing human resource competency, and advancing clinical trial implementation.

 

Prodia the CRO, believes that this cooperation will result in a positive impact on clinical trials in Indonesia. This cooperation has the chance to increase both the number and quality of clinical studies while guaranteeing that they are carried out in a transparent, ethical, and GCP standard. Furthermore, we believe that this synergy approach will make Indonesia more appealing for clinical trials in global markets.

Prodia the CRO is a Contract Research Organization (CRO) based in Indonesia which provides GCP-based Clinical Trial supports through our integrated and wide range of services. Prodia the CRO has accumulated many experiences providing services to local as well as multinational companies with commitment to reach quality through qualified and dedicated resources. It provides customers in GCP trials with competitive costs, firm timeliness, high compliance to ICH-GCP guidelines.

The Prodia CRO team attended the launch of the Indonesia Clinical Research Center (INA-CRC) which was inaugurated by the Ministry of Health of the Republic of Indonesia at the Eijkman Building, dr. Cipto Mangunkusumo Hospital (RSCM) on October 16, 2024. The INA-CRC launch was attended by Prodia the CRO’s team, represented by Erizal Sugino (Director) and  Ida Paulina (SMO Manager).

This is a significant leap as part of the transformation of clinical research in Indonesia. In order to facilitate and coordinate Clinical Research Units (CRU) in all Indonesian hospitals, INA CRC was founded in accordance with the Decree of the Minister of Health of the Republic of Indonesia No. HK.01.07/MENKES/1458/2023 about the Implementation of Clinical Research in Hospitals.

INA-CRC will boost Indonesia as regional clinical research hub whileplaya a role in the advancement of the transformation of clinical research in Indonesia. INA CRC is dedicated to improving national competitiveness in the health sector, driving health innovation, and emerging as a major force in international clinical research. Additionally, it will make Indonesia more competitive and appealing to both domestic and foreign enterprises as a clinical research site. The Indonesian Minister of Health said that INA CRC is the missing piece of clinical trial and health innovation in Indonesia.

Furthermore, Prodia the CRO believes that clinical trials in Indonesia may be transformed and synergized with a strong commitment from every stakeholder. According to Dr. Ida Paulina, Site Management Manager of Prodia the CRO, INA CRC is a collective aspiration that has now come into reality and is anticipated to improve clinical research unit among hospitals in Indonesia. INA CRC is expected to contribute significantly to the advancement of medical innovation in Indonesia. Prodia the CRO gives its utmost commitment working with INA CRC in delivering highest quality for clinical trials through clinical research unit establishment in hospitals across Indonesia. As the first actions after its inauguration, INA-CRC launch the initiative to transform clinical trial implementation in Indonesian. Those are the re-branding Indonesian clinical registry and simplified material transfer agreement (MTA) submission. With this transformation, sponsors will have certainty in both timeline and approval process.

About Prodi the CRO. Prodia the CRO is a Contract Research Organization (CRO) based in Indonesia which provides GCP-based Clinical Trial supports through our integrated and wide range of services. Prodia the CRO has accumulated many experiences providing services to local as well as multinational companies with commitment to reach quality through qualified and dedicated resources. It provides customers in GCP trials with competitive costs, firm timeliness, high compliance to ICH-GCP guidelines.

The Indonesian Association for The Study of Medicinals (IASMED) will hold the Virtual Course & Workshop on Applied Good Clinical Practice (GCP) on 20 – 21 September 2024. This training has been recognized by TransCelerate BioPharma.

The speakers are clinical trial experts & practitioners in Indonesia that will share useful information for conducting and evaluating clinical trials. Participant will be involved in interactive workshop and case-study application for Good Clinical Practice principle in clinical trial.

To participate on this event, please register at: https://bit.ly/GCPIASMED

[Bandung, Indonesia] On 20 July 2024, Prodia the CRO attended the 5^th annual meeting of the Association of Public University Hospital / Asosiasi Rumah Sakit Perguruan Tinggi Negeri (ARSPTN) in Bandung.

The existence of public universities hospital began when the Ministry of Health issued temporary permits for seven dental and oral hospitals (RSGM) belonging to public universities (perguruan tinggi negeri) simultaneously on 27 June 2002. These seven dental and oral hospitals were belonging to University of North Sumatra, University of Indonesia, Padjadjaran University, Gadjah Mada University, Hasanuddin University, Airlangga University, and Jember University.

Meanwhile, general hospitals (RSU) that belong to the public universities began with the establishment of hospitals that belong to Gadjah Mada University and Hasanuddin University in 2010, followed by hospital that belong to Airlangga University in 2011. Other public university hospitals were established afterwards in many places according to the Ministry of Research, Technology and Higher Education (Kemenristekdikti) program at those time. In 2023, there were 39 public universities hospitals that consisted of 25 general hospitals and 14 Dental and Oral Hospitals.  The dynamics in managing public universities hospitals creating a sense of togetherness which was later manifested in the establishment of ARSPTN on 28 October 2017 in Surabaya.  To exchange ideas and experiences, ARSPTN routinely held an annual meeting. In 2024, the fifth ARSPTN annual meeting was held in Trans Luxury Hotel Bandung on 19-21 June 2024 and hosted by Padjajaran University Oral and Dental Hospitals. This meeting was attended by representatives from many public universities teaching hospital in Indonesia.  The theme of this 5^th annual meeting is “Strengthening Hospital Competitiveness in the New Era Post the Implementation of Undang-undang No. 17 tahun 2023 regarding Health”

On the fifth ARSPTN Annual Meeting, two MURI (Indonesia World Records Museum) records were broken that are MURI World Records on Playing Angklung to accompany HIV song by the largest number of health care workers and MURI Indonesia Records: interprofessional education program with the largest number of students.

Prodia the CRO was one of the Sponsors for the ARSPTN 5^th annual meeting. During this meeting, Dr. apt. Ida Paulina Sormin, M.Si, as a Site Management Organization Manager (SMO) of Prodia the CRO, gave a short presentation about the Development of Clinical Research Unit (CRU) for improving Clinical Trials in Indonesia. During the event, Prodia the CRO was also inviting the public university hospitals to collaborate with SMO for Clinical Research Unit Development.

As a leading CRO company in Indonesia, Prodia the CRO keeps on taking steps forward and strives to be in our best potential. Being the award-winner of this category for 2 years in a row increases our confidence as well as our eagerness to improve our services, to adapt more and dive deeper into this industry and give better support to our customers and partners.

Referring to Frost & Sullivan’s report, Asia-Pacific’s (APAC) contract research organization (CRO) space has matured since the COVID-19 pandemic. The region’s significance in the industry is due to a notable increase in clinical research activities, particularly during the pandemic. Thanks to evolving trial dynamics, countries like Indonesia increasingly draw drug sponsors and CROs with well-developed infrastructure and diverse demographics. Prodia the CRO with our expertise and established networking across the country, and through our local-wise understanding about the clinical trial environment, always try to ensure that the desired goal of the clinical trials which is to obtain the best research outcome in the most effective way, efficient cost and timeline, without neglecting the rights of the patients and ethical aspects of the procedures, could be reached by great trial management throughout project preparation and conduct.

This recognition is the result of many individuals: hard work of our employees, and ultimately, the trust of our customers, partners, and investors who make critical decisions every day to support Prodia the CRO and contribute to our future. Thank you for believing in Prodia the CRO. <BAN>

[Jakarta, Indonesia] — The Ministry of Health of the Republic of Indonesia issued a Ministry of Health Decree Number HK.01.07/MENKES/1458/2023 about Clinical Research Conduct in Hospital. In order to respond to the technological development in medicine and the increase of health problems complexity, the hospitals need to perform clinical research and innovation to improve health services in the hospital. To carry out the clinical research in hospital, it is necessary to conduct:

1. Indonesia Clinical Research Center (INA-CRC)
2. Clinical Research Unit (CRU)

As stipulated in this decree, the Clinical Research Unit (CRU) should be established in government-owned hospital, regional government hospital and private hospital. The CRU will be responsible for managing clinical research performed in the hospital.

In collaboration with the Directorate of Health Services Governance, Ministry of Health of The Republic of Indonesia, The Indonesia Association for The Study of Medicinals (IASMED) organized a Clinical Research Unit (CRU) Virtual Workshop on 21 December 2023. This workshop was attended by more than 300 participants from hospitals throughout Indonesia. It is a series of CRU webinar that has been held by IASMED since 14 November 2023.

There are two sessions and four topics presented in this workshop. The first topic discussed The Quality Management System in Hospitals, and the second session discussed the Standard Operating Procedure and Guidance of Performing Clinical Research in Hospitals. There are discussion sessions and case studies at the end of the sessions. Ms. Ida Paulina Sormin, Site Management Organization (SMO) Manager of Prodia the CRO, was given opportunity to present about the quality management system of CRU, SOP and guidance in performing clinical research in hospital. <IIR>

[Padang, Indonesia] — RSUP Dr. M. Djamil Padang launches Clinical Research Unit (CRU) on Wednesday, 30 August 2023 and performing hybrid Good Clinical Practice (GCP) training on 30 – 31 August 2023. CRU Development and the GCP training were performed in collaboration with The Indonesian Association for The Study of Medicinals (IASMED) and Prodia the CRO.

As stipulated in the Decree of the Ministry of Health of the Republic of Indonesia Number HK.01.07/MENKES/1458/2023 regarding clinical research in hospitals, to perform clinical research in hospital, Clinical Research Unit should be established. The establishment of CRU is carried out to strengthen both quality and capacity in performing clinical research in hospital. Therefore, the clinical research that is performed in hospital can meet the applicable requirements and standards. RSUP M. Djamil Padang is collaborating with IASMED and the Site Management Organization (SMO) Department of Prodia the CRO for the CRU Development. These collaborations include site assessments, developing clinical research related standard operating procedures (SOP) and guidance of performing clinical research in hospital.

Along with CRU Launching, the Hybrid GCP training was also conducted by the hospital to ensure that all staff are trained and understand how to conduct Clinical Trial based on GCP standard. This course consists of 10 topics started from the Introduction of International Conference of Harmonization – Good Clinical Practices (ICH-GCP), Roles and Responsibility of Ethical Committee, Investigator Responsibilities, Sponsor & CRO Responsibilities and Preparation of Trial Site. These topics were presented by practitioners and experts in clinical trials. This GCP training was attended by 56 participants from RSUP Dr. M. Djamil Padang. During this training, all participants were enthusiastic in all sessions. In the end of the training, the participants took some test and obtained the certificate. <IIR>

 

 

JAKARTA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with Faculty of Dentistry in Trisakti University on 18-19 February 2019. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is held by the faculty to ensure all the dentists who work as a lecturers and faculty staffs trained and understand how to conduct a good clinical research, since many of them work in Trisakti Dental and Oral Hospital and conducting clinical research is a priority. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical trial data.

Triskati University is one of the largest private university in Indonesia that is located in Jakarta. In this course, there was 30 participants attended who are all dentists. During this event, all the participants were enthusiastically participated in all the sessions. Thus, they received both the certificate of attendance and competence.

SURABAYA – The Course and Workshop on Good Clinical Practice (GCP) was held by PT. Prodia Diacro Laboratories (Prodia the CRO), the Indonesian Association for The Study of Medicinals (IASMED) in collaboration with Faculty of Medicine in Airlangga University on 29-30 November 2018. This course consists of 10 topics started from the introduction of the International Conference of Harmonization – Good Clinical Practice up to Sponsor/Contract Research Organization (CRO) Responsibilities. This course is held by the faculty to ensure all the clinicians who work as lecturers and faculty staffs trained and understand how to conduct a good clinical research. Hence, this ensures the protection of the subjects’ safety, rights and wellbeing and the reliability of clinical data.

Airlangga University is one of the oldest in Indonesia and a state university that is located in Surabaya. In the faculty of medicine, there are 29 departments supporting the pre-clinical and clinical studies in Medical Doctor Program. The course was attended by 47 participants. All the participants are clinicians from various science backgrounds such as pharmacology, neurology, physiology, etc. During this event, all the participants were enthusiastically participated in all the sessions. At the end, they received both the certificate of attendance and competence.